Reimagining Healthcare

  In this two-part article on the drug development process, we are discussing the typical life cycle for developing a new drug and comparing it with the fast-tracked process for releasing COVID-19 vaccine. In part 1 , we looked at a typical lifecycle for developing a new drug spanning anywhere between 12-15 years. In this part of the article, we will discuss the process followed for developing the Covid-19 vaccine. Drug Development Timeline for Covid-19 Vaccine March 17 - Pfizer and BioNTech announced collaboration to co-develop a vaccine. April 22 - BioNTech and Pfizer gained approval from German regulatory authority to begin Phase 1 clinical trial. The two companies started Phase 1/2 trials in Germany to examine safety, immunogenicity and optimal dosage testing for 4 initial vaccine candidates. To accelerate Covid-19 vaccine process, all 4 candidates moved in parallel during the Clinical trials phase. July 13 - Phase 2/3 trials commenced for safety and efficacy examination for tw...

On March 17 th 2020, Pfizer and BioNTech companies announced that the companies have agreed to a letter of intent regarding the co-development and distribution of a potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection 1 . Today, on November 18 th 2020, Pfizer and BioNTech concluded phase 3 study of covid-19 vaccine candidate with 95% efficacy 2 .  But, what does this mean? When can we expect to have a vaccine available for public use in the marketplace? What are the different phases in a drug discovery & development process? In this two-part article on the drug development process, we will look at a typical lifecycle for developing a new drug and compare it with the fast-tracked process for releasing COVID-19 vaccine in Part 2 . Since Pfizer and BioNTech are following US FDA approval process, let us understand the typical drug development process in the US. Note that every country has its own regulatory agency. The regulatory agency in USA is the US...